Empower Pharmacy
Quality Control Analyst I - EM 503B
Houston, TX
Sponsorship not specifiedDetected 7 days ago
Data AnalysisComplianceProcess ImprovementHRISGMPFDA RegulatoryLeadershipCommunicationCollaborationAdaptability
About the role
- The Product and Labeling Inspector ensures product integrity, labeling accuracy, and regulatory compliance across 503A and 503B operations.
Responsibilities
- Visual Verification: Perform detailed inspections of products and labels ensuring accuracy, compliance, and defect-free release using AI-assisted detection tools.
- Batch Review: Validate batch records, ensuring completeness, traceability, and alignment with GMP requirements using AI-supported document analysis tools.
- Deviation Identification: Detect, document, and escalate discrepancies in products or labeling using AI-driven anomaly detection and reporting systems.
- Audit Support: Prepare inspection data and documentation to support internal and external audits, ensuring readiness and accuracy at all times.
- Data Utilization: Analyze inspection data trends using AI tools to drive proactive quality improvements and reduce recurring issues.
- Standard Adherence: Maintain strict adherence to SOPs while contributing to updates based on operational feedback and inspection outcomes.
- Customer Focus: Builds trust through customer-centric solutions.
- Optimizes Work Processes: Drives efficiency with continuous improvement.
- Collaborates: Partners effectively to achieve shared goals.
- Manages Complexity: Simplifies and solves complex challenges.
Requirements
- While performing the responsibilities of the job, the employee is required to talk and hear.
- Employees are regularly required to move about the office and around the corporate campus.
- The employee is regularly required to stand, walk, reach with arms and hands, climb or balance, and to stoop, kneel, crouch or crawl.
- Minimum two years experience in pharmaceutical manufacturing, quality inspection, or regulated production environment with proven performance.
- Proven ability to use digital or AI tools to enhance inspection accuracy, reporting efficiency, and quality outcomes.
- Demonstrated success identifying defects, ensuring compliance, and supporting audit readiness in high-throughput operations environments.
- Experience working within 503A or 503B environments or similarly regulated pharmaceutical or healthcare manufacturing settings.
Skills
- Strong understanding of GMP, 503A/503B regulations, and quality systems within pharmaceutical manufacturing environments.
- Ability to leverage AI tools for inspection accuracy, data analysis, and continuous improvement initiatives effectively.
- High attention to detail with strong analytical and systems-thinking capabilities in regulated production environments.
- Effective communication and documentation skills ensuring clarity, compliance, and cross-functional alignment under pressure.
- Ensure inspections meet 503A and 503B regulatory requirements using AI tools to monitor compliance deviations and trends.
- The inspector leverages AI-enabled tools to detect anomalies, streamline documentation, and enhance inspection consistency.
Benefits
- We offer comprehensive benefits to support your health, well-being, and future, including medical, dental, and vision coverage, paid time off, 401(k) matching, wellness perks, IV therapy, and compounded medications.
Company info
- Empower Pharmacy is a visionary healthcare company dedicated to making quality, affordable medication accessible to millions of patients nationwide.
- As the nation's most advanced 503A compounding pharmacy and FDA-registered 503B outsourcing facility, we're redefining what's possible in personalized medicine and pharmaceutical manufacturing.
- We're proud to be recognized as one of Houston's fastest-growing private companies and ranked #116 in Healthcare & Medical on the Inc.
- 5000 List for 2025.
- Empowering people defines who we are.
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This listing is sourced directly from Empower Pharmacy's careers page and normalized into a canonical job model.